Nerve BlockNCT05837702
Pain Management in Laparoscopic Cholecystectomies
A study testing ESPB and PVB in people with Nerve Block, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block
- What is being tested?
- ESPB and PVB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged >18 years
- patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery
Who cannot join
- Did not provide informed consent,
- Had any psychiatric or mental problem that prevented understanding of the informed consent form
- They were planned to undergo emergency cholecystectomy,
- Had any allergy or hypersensitivity to local anaesthetic,
- Had an infection in the needle entry area
- History of coagulopathy or the use of anticoagulants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun University Medical School Hospital.
Giresun, Merkez, 28100
About this study
Official title: Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.
Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.
Read the detailed description
The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.
- Conditions
- Nerve Block
- Being tested
- ESPB, PVB, CONTROL
- Keywords
- Erector Spinae Plane Block, Paravertebral Block, Laparoscopic Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPBProcedure or surgery
Erector spinae plane block
PVBProcedure or surgery
Paravertebral Block
CONTROLProcedure or surgery
No block has been done
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | The spinous processes of the vertebrae were marked up to T8 level. After providing antisepsis of the skin with 10% povidone iodine, the ultrasound probe was placed at T8 level parallel to the vertebral spine at T8. The transverse process (TP) and hyperechoic pleura were observed 2.5cm right lateral of the spinous process. Using the in-plane approach, the needle was placed in the caudal direction. After confirming displacement of the pleura with 0.5-1ml local anaesthetic (LA), 20ml 0.25% bupivacaine was administered for the block . Receives: Procedure: ESPB |
| Paravertebral Block (PVB) | Active comparator | After sterilisation of the skin with povidone iodine, the probe covered with a sterile sheath was placed 3cm lateral of the T8 spinous process. The trapezius, rhomboid major, and erector spinae muscles, and the TP of the vertebrae were visualised. The needle was placed craniocaudally within the fascial plane of the deep surface of the erector spina muscle above the bone shadow of the TP. The fluid dissemination was confirmed by raising the placement of the needle tip towards the erector spina muscle. 20ml 0.25% bupivacaine was applied to this region and the spread of local anaesthetic was observed Receives: Procedure: PVB |
| Control | Active comparator | No block has been done Receives: Procedure: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total tramadol consumption
Consumption at the end of 24 hours will be monitored by planning a 10mg bolus, a 10-minute lock-in time, through a patient-controlled analgesia device.
Measured: 24 hours postoperatively
Secondary outcomes (6)
Visual analog scale (VAS) at rest and when coughing
11-point scale where 0=no pain and 10=worst pain
Measured: at 0, 5, 10,20 minutes and 1, 2,4 , 6, 12 and 24 hours postoperatively
Analgesic drug consumption other than tramadol
in mg
Measured: 24 hours postoperatively
Heart Rate
beats /min
Measured: preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)
Mean arterial pressure (MAP)
mm-hg
Measured: preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)
Incidence of postoperative nausea & vomiting (PONV)
Number of patients developing PONV
Measured: 24 hours postoperatively
Shoulder pain
Number of patients developing shoulder pain
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start10 Jan 2022
- Primary completion10 Oct 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvan Yilmaz, Giresun University
- Investigators
- elvan tekir yilmaz, Study director, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837702
- Sponsor's protocol ID
- 2021/ 283
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.
- ClinicalTrials.gov ID
- NCT05837702
- Acronym / sponsor ID
- 2021/ 283
- Conditions
- Nerve Block
- Keywords
- Erector Spinae Plane Block, Paravertebral Block, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.
Detailed description
The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block (ESPB) | Experimental | Procedure: ESPBThe spinous processes of the vertebrae were marked up to T8 level. After providing antisepsis of the skin with 10% povidone iodine, the ultrasound probe was placed at T8 level parallel to the vertebral spine at T8. The transverse process (TP) and hyperechoic pleura were observed 2.5cm right lateral of the spinous process. Using the in-plane approach, the needle was placed in the caudal direction. After confirming displacement of the pleura with 0.5-1ml local anaesthetic (LA), 20ml 0.25% bupivacaine was administered for the block . |
| Paravertebral Block (PVB) | Active comparator | Procedure: PVBAfter sterilisation of the skin with povidone iodine, the probe covered with a sterile sheath was placed 3cm lateral of the T8 spinous process. The trapezius, rhomboid major, and erector spinae muscles, and the TP of the vertebrae were visualised. The needle was placed craniocaudally within the fascial plane of the deep surface of the erector spina muscle above the bone shadow of the TP. The fluid dissemination was confirmed by raising the placement of the needle tip towards the erector spina muscle. 20ml 0.25% bupivacaine was applied to this region and the spread of local anaesthetic was observed |
| Control | Active comparator | Procedure: CONTROLNo block has been done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged >18 years
- patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery
Key exclusion criteria (6 listed)
- Did not provide informed consent,
- Had any psychiatric or mental problem that prevented understanding of the informed consent form
- They were planned to undergo emergency cholecystectomy,
- Had any allergy or hypersensitivity to local anaesthetic,
- Had an infection in the needle entry area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESPBErector spinae plane block | Procedure or surgery | Erector Spinae Plane Block (ESPB) |
| PVBParavertebral Block | Procedure or surgery | Paravertebral Block (PVB) |
| CONTROLNo block has been done | Procedure or surgery | Control |
Primary outcome
Total tramadol consumption
Time frame: 24 hours postoperatively
Consumption at the end of 24 hours will be monitored by planning a 10mg bolus, a 10-minute lock-in time, through a patient-controlled analgesia device.
6 secondary outcomes
Visual analog scale (VAS) at rest and when coughing
Time frame: at 0, 5, 10,20 minutes and 1, 2,4 , 6, 12 and 24 hours postoperatively
Analgesic drug consumption other than tramadol
Time frame: 24 hours postoperatively
Heart Rate
Time frame: preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)
Mean arterial pressure (MAP)
Time frame: preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes)
Incidence of postoperative nausea & vomiting (PONV)
Time frame: 24 hours postoperatively
Shoulder pain
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
elvan tekir yilmaz study director
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPB and PVB in people with Nerve Block, run by Giresun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total tramadol consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.